Soluble Corn Fiber and Calcium Utilization in Adolescents

Not Applicable

Completed

• Conditions: Osteoporosis
• Interventions: Dietary Supplement: No soluble corn fiber; Dietary Supplement: 12 g soluble corn fiber

• Registration Number: NCT01571440
• Lead Sponsor: Purdue University

Brief Summary

The purpose of this study was to determine the effect of soluble corn fiber on calcium absorption and retention and gut microflora in adolescent boys and girls.

Detailed Description

In a previous study, soluble corn fiber (SCF) was found to greatly enhance calcium utilization and bone properties in a growing rat model. Because factors that enhance bone density and mineral content can potentially result in a skeleton that will resist fracture later in life, it is important to investigate this potential in adolescents. Therefore, the objective of this study was to determine the effect of SCF on calcium absorption and retention in adolescent boys and girls. A second objective of this study was to assess whether additional dietary fiber leads to changes in gut microflora which may influence calcium absorption. During this two-phase metabolic camp participants consumed packages of fruit snacks supplemented with either 0 or 6 grams of soluble corn fiber twice a day during the first phase of the study, and switch to the opposite treatment during the second phase, with a 2-week washout period in between. Subjects collected all excreta during both phases and calcium absorption, gut microbiota, height, weight, and bone density were evaluated throughout the 6-week period of the study.

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted: 2011-01-12
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-05
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-07
• Last Update Posted: 2014-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Normal, healthy, white adolescents (Hispanic or non-Hispanic)
• Boys age 13-15
• Girls age 12-14

Exclusion Criteria

• Abnormal kidney or liver function
• Malabsorptive disorders
• Anemia
• Smoking
• History of medications that affect calcium metabolism
• Body weight outside 5-95 percentile body mass index (BMI) for age
• Regular consumption of illegal drugs
• Contraceptive use
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
No Soluble Corn Fiber	No soluble corn fiber	Each teen will receive a package of fruit snacks containing 0 g soluble corn fiber two times daily.
12 g Soluble Corn Fiber	12 g soluble corn fiber	Each teen will receive a package of fruit snacks containing 6 g soluble corn fiber two times daily

Primary Outcome Measures

Name	Time	Method
Calcium absorption and retention	up to three weeks
Gut microbial profile	up to three weeks

Secondary Outcome Measures

Name	Time	Method
Bone mineral content and density	up to three weeks

Trial Locations

Locations (1)

Purdue University; 🇺🇸 West Lafayette, Indiana, United States